Atherectomy catheter with shapeable distal tip

ABSTRACT

An atherectomy catheter for use in a vessel includes an elongate catheter body and an annular cutter. The elongate catheter body includes a fixed jog section with a pre-set curvature and a flexible section that has a greater flexibility than a remainder of the elongate catheter body. The fixed jog section and flexible section are formed of a frame including a plurality of circumferential slits therein. Also described herein is an atherectomy catheter for use in a vessel includes an elongate catheter body, an annular cutter, and an s-shaped curved portion in the elongate catheter body. The curved portion includes a frame having a longitudinal proximal spine and a longitudinal distal spine. The longitudinal proximal spine is positioned approximately 180 degrees away from the longitudinal distal spine.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationNo. 62/357,173, filed Jun. 30, 2016, and titled “ATHERECTOMY CATHETERWITH SHAPEABLE DISTAL TIP,” which is herein incorporated by reference inits entirety.

This application may also be related to U.S. Publication No.20150141816, titled “ATHERECTOMY CATHETER WITH IMAGING,” filed on Mar.15, 2013, which is herein incorporated by reference in its entirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

FIELD

Described herein are devices for treatment of an occluded body lumen,such as for the removal of occlusive materials from blood vessels. Inparticular, described herein are atherectomy catheters that are adaptedto easily maneuver against tissue and plaque buildup within vessels fordebulking.

BACKGROUND

Atherosclerosis is disease in which accumulation of atheromatousmaterials builds up inside a person's arteries. Atherosclerosis occursas part of the natural aging process, but may also occur due to aperson's diet, hypertension, vascular injury, heredity, and so forth.Atherosclerosis can affect any artery in the body, including arteries inthe heart, brain, arms, legs, pelvis, and kidneys. Atherosclerosisdeposits may vary in their properties as well. Some deposits arerelatively soft, other types may be fibrous, some are calcified, or acombination of all three. Based on the location of the plaqueaccumulation, different diseases may develop. For example, coronaryheart disease occurs when plaque builds up in the coronary arteries,which supply oxygenated blood to the heart. If plaque buildup blocks thecarotid artery, arteries located on each side of the neck that supplyoxygen to the brain, a stroke may be the result.

Atherosclerosis may be treated in a number of ways including medication,bypass surgery, and catheter-based approaches. Atherectomy proceduresinvolve excising or dislodging materials that block a blood vessel. Manyatherectomy catheters typically have a substantially straight centralaxis. However, atherectomy catheters having a straight profile may bedifficult to maneuver close enough to the inner surface of the arterialwalls to remove all plaque buildup. Moreover, plaque removal can becomplicated with such straight profile catheters when plaque formationsaccumulate in the curves and more tortuous portions of an artery.

The atherectomy catheters described herein address some of thesechallenges.

SUMMARY OF THE DISCLOSURE

In general, in one embodiment, an atherectomy catheter for use in avessel includes an elongate catheter body and an annular cutter. Theelongate catheter body includes a fixed jog section with a pre-setcurvature and a flexible section that has a greater flexibility than aremainder of the elongate catheter body. The fixed jog section andflexible section are formed of a frame including a plurality ofcircumferential slits therein.

This and other embodiments can include one or more of the followingfeatures. The frame in the fixed jog section can further include alongitudinal spine extending therethrough that does not have slits. Theatherectomy catheter can further include a cutting window through whichthe annular cutter extends. The cutting window can be positioned distalof the fixed jog section and the flexible section so as to urge thecutter into the vessel. The atherectomy catheter can further include atleast one laminating layer positioned over or under the frame of thefixed jog section. The laminating layer can be made of a polymer. Theframe can be made of metal. The plurality of circumferential slits canbe arranged in a repeating pattern. The fixed jog section can form anangle of 130° to 160° in the elongate catheter body. The frame canfurther include an annular spine without slits that extends between thefixed jog section and the flexible section. The flexible section can beconfigured to passively bend to angles of 130°-160°.

In general, in one embodiment, an atherectomy catheter for use in avessel includes an elongate catheter body, an annular cutter, and ans-shaped curved portion in the elongate catheter body. The curvedportion includes a frame having a plurality of annular spines connectedtogether by a longitudinal proximal spine and a longitudinal distalspine. The longitudinal proximal spine is positioned approximately 180degrees away from the longitudinal distal spine.

This and other embodiments can include one or more of the followingfeatures. The plurality of annular spines can include a first annularspine, a second annular spine, and a third annular spine. Thelongitudinal proximal spine can connect the first annular spine and thesecond annular spine, and the longitudinal distal spine can connect thesecond annular spine and the third annular spine. The atherectomycatheter can further include a cutting window through which the annularcutter extends. The cutting window can be positioned distal of thecurved portion and on an outer circumference of the s-shaped curve so asto urge the cutter into the vessel. The s-shaped curved portion can beconfigured to be activated by pulling or pushing on a shaft of theatherectomy catheter. The atherectomy catheter can further include atleast one laminating layer positioned over or under the frame. Thelaminating layer can be made of a polymer. The frame can be made ofmetal. The distal longitudinal spine can be positioned adjacent to anexposed portion of the cutter. The distal longitudinal spine can be on asame side of the elongate catheter body as the exposed portion of thecutter. The longitudinal proximal spine can form a first angle, and thelongitudinal distal spine can form a second angle. The first and secondangles can extend in opposite directions, and the first angle can bebetween 140 and 160 degrees and the second angle can be between 140 and160 degrees. A distal-most spine of the plurality of spines can includea beveled distal edge. The atherectomy catheter can further include anosecone configured to pivot away from the elongate body to expose thecutter. The bevel can be configured to provide space for the nosecone topivot.

In general, in one embodiment, an atherectomy catheter for use in avessel includes an elongate catheter body, an annular cutter, and ans-shaped curved portion in the elongate catheter body. The curvedportion includes a frame having a proximal section and a distal section.The proximal section has a plurality of circumferential proximal slitsand a longitudinal proximal spine without slits, and the distal sectionhaving a plurality of circumferential distal slits and a longitudinaldistal spine without slits. The longitudinal proximal spine ispositioned approximately 180 degrees away from the longitudinal distalspine.

This and other embodiments can include one or more of the followingfeatures. The atherectomy catheter can further include a cutting windowthrough which the annular cutter extends. The cutting window can bepositioned distal of the distal section and on an outer circumference ofthe s-shaped curve so as to urge the cutter into the vessel. Thes-shaped curved portion can be configured to be activated by pulling orpushing on a shaft of the atherectomy catheter. The atherectomy cathetercan further include at least one laminating layer positioned over orunder the frame. The laminating layer can be made of a polymer. Theframe can be made of metal. The plurality of circumferential proximalslits can be arranged in a first repeating pattern, and the plurality ofcircumferential distal slits can be arranged in a second repeatingpattern. The first repeating pattern and the second repeating patterncan be circumferentially offset from one another. The distallongitudinal spine can be positioned adjacent to an exposed portion ofthe cutter. The distal longitudinal spine can be on a same side of theelongate catheter body as the exposed portion of the cutter. Theproximal section can form a first angle, and the distal section forms asecond angle. The first and second angles can extend in oppositedirections, and the first angle can be between 140 and 160 degrees andthe second angle can be between 140 and 160 degrees. The frame canfurther include an annular spine without slits extending between theproximal section and the distal section.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1A shows an atherectomy catheter having a fixed jog.

FIG. 1B shows the atherectomy catheter of FIG. 1A in a vessel.

FIG. 2 shows a drawing of the atherectomy catheter of FIG. 1A withrelative angles and dimensions.

FIG. 3A shows a variation of a distal end of an atherectomy catheterthat includes a user-activated curved portion with stiffening membersthat cause the catheter to deform to a predetermined curvedconfiguration when activated.

FIG. 3B is a schematic showing the stiffening members of the atherectomycatheter of FIG. 3A.

FIGS. 4A and 4B show another embodiment of an atherectomy catheter witha distal curved portion.

FIG. 5A is a top view of a user-activated curved portion of anatherectomy catheter.

FIGS. 5B and 5C are perspective views of the curved portion of FIG. 5A.

FIG. 5D is a flattened view of the curved portion of FIG. 5A.

FIG. 6A shows an atherectomy catheter including another embodiment of auser-activated curved portion.

FIG. 6B shows the frame of the curved portion of FIG. 6A includingannular and longitudinal spines.

FIG. 6C shows a side view of the spine of FIG. 6B.

FIG. 6D shows a cross-sectional view of the spine of FIG. 6B.

FIG. 6E is a flattened view of the spine of FIG. 6B.

FIG. 7A shows a portion of an atherectomy catheter including a fixed jogsection and a flexible section.

FIG. 7B shows a flattened view of the curved portion of the catheter ofFIG. 7A.

FIG. 8A shows an exemplary flexible nosecone for use with an atherectomycatheter.

FIG. 8B shows a flattened view of a portion of the nosecone of FIG. 8A.

DETAILED DESCRIPTION

Described herein is an atherectomy catheter having an elongate body witha curved distal portion, a nosecone and a rotatable annular cutter. Thecurved portion (which can otherwise be called a bent/bendable portion orjog mechanism) can advantageously be used to push the cutter up againstthe vessel wall to enhance the efficiency of cutting.

FIGS. 1A and 1B show an exemplary atherectomy catheter 100 having acurved portion along the elongate catheter body. Referring to FIGS.1A-2, the atherectomy catheter 100 can include a catheter body 101 witha curved portion 133, a rotatable annular cutter 103 at a distal end ofthe catheter body 101, and a nosecone 105 at a distal end of thecatheter body 101. The nosecone 105 can include a cutting window 107configured to allow the cutter 103 to cut therethrough. The catheter 101can further include a curved portion 133 in the catheter body 101 toradially push the cutter 103 against the vessel wall.

The curved portion 133 can be a fixed jog (i.e., have a pre-set shape).Further, the curved portion can be curved or bent such that the cuttingwindow 107 is on the radially outermost portion of the curved portion133 (thereby allowing the cutting window 107 to be urged against avessel wall in use). In one embodiment, the curved portion 133 can bepre-formed, for example, by using pre-deflected shaped-set nitinolribbon segments embedded in the outer shaft. The curved portion 133 canhave two inflection points 155, 166 of opposite curvature (i.e., onecurving up and the other curving down) so as to form an approximate “s”shape. In one embodiment, the s-shape can be configured such that adistal end of the catheter body 101 is offset from, but substantiallyparallel to, a proximal end of the catheter body 101. In otherembodiments, the distal end and proximal ends of the catheter body 101can be at a slight angle to one another so as to control the angle ofcutter engagement with the vessel wall.

Thus, as shown in FIG. 2, the “s-shape” of the curved portion 133 caninclude a proximal section 137 have a length b that extends from thecenter of the distal inflection point 155 to the center of the proximalinflection point 166. Further, the curved portion 133 can include adistal section 135 having a length a that extends from the cutting edge112 to the center of the distal inflection point 155. Further, there canbe distal angle 1 at the distal end of the “s-shape” and a proximalangle 2 at the proximal end of the “s-shape.” These lengths (a, b) andangles (1, 2) can be tuned to achieve the desired jog or offset in orderto obtain optimum apposition to tissue walls. For example, the length acan be shorter than the length b to ensure that the cutter is as closeto the angle 1 as possible, thereby providing better apposition of thecutter 303. The angles 1 and 2 can be between 120 and 180 degrees, suchas between 140 and 160 degrees. In one example, the length a is between5 and 10 mm, the length b is between 10 and 15 mm, the angle 1 is 140degrees and angle 2 is 160 degrees for a catheter configured to be usedin a vessel having a 2.5-4 mm diameter.

The curved portion 133 can advantageously radially push the distal endof the catheter against a vessel wall 200, thereby enabling optimizedcutting and/or imaging of the vessel as shown in FIG. 1B.

FIGS. 3A-3B show another embodiment of an exemplary catheter 300 thatincludes a curved portion 333 in the catheter body that urges theatherectomy cutter against the vessel wall. The curved portion 333 canhave similar dimensions and features as curved portion 133. In contrastto the fixed jog curved portion 133 of catheter 100, however, the curvedportion 333 can be a user-activated jog. Thus, referring to FIGS. 3A and3B, the catheter 300, can be deflected into a curved portion 333 bytensile and compressive interaction between an inner shaft 313 (whichcan be a drive shaft for a cutter) and outer shaft 311 that are fixedtogether at the distal end but free to move relative to one another atthe proximal end. The outer shaft 311 can include stiffening members 377a,b, such as nitinol or stainless steel, stiffening members, configuredto bias the deflection to a set shape. As shown in FIG. 3B, there can betwo stiffening members 377 a, 377 b that can be axially aligned with theouter shaft 311 and axially and radially offset from one another. As aresult, when compression is applied on the outer shaft 311 (such as bypulling on the inner shaft 313 or a separate pullwire or shaft), theportions 379 a,b of the outer shaft opposite to the stiffening members377 a,b will contract. The contraction of the two portions 379 a, 379 bwill result in an s-shape similar to the catheter 100 shown in FIG. 1.As a result, the catheter will deflect into jog or s-shapedconfiguration where the distal end of the shaft is offset and parallelto the main shaft body. It is to be understood that other numbers andarrangements of stiffening members are possible, as are other resultingjog shapes.

Another embodiment of an atherectomy catheter 400 including auser-activated curved portion 433 is shown in FIGS. 4A-4B. Theatherectomy catheter 400 includes an elongate body 401, a nosecone 405attached thereto, and a cutting window 407 configured to expose anannular cutter 411 therethrough. Moreover, the catheter 400 includes acurved portion 433. The curved portion 433 includes curved sections 425,426 of opposite curvatures (i.e., one curving up and the other curvingdown) so as to form an approximate s-shape. In one embodiment, thes-shape can be configured such that the distal end of the catheter body401 and/or the nosecone 405 is offset from, but substantially parallelto, a proximal end of the catheter body 401. In another embodiment, thedistal end of the elongate body 401 and/or the nosecone 405 forms anangle relative to a proximal end of the catheter body 401.

Thus, as shown in FIG. 4B, the “s-shape” of the jog 433 can have aproximal curved section 426 and a distal curved section 425 having alength c. Further, there can be distal angle 1 at the distal end of the“s-shape” and a proximal angle 2 at the proximal end of the “s-shape.”The lengths (c, d) and angles (1, 2) of the jog 433 can be tuned toachieve the desired jog or offset in order to obtain optimum appositionto tissue walls. For example, the angles 1 and 2 can be between 120 and175 degrees, such as between 140 and 160 degrees. Further, in someembodiments, the length d of the proximal section 426 is greater thanthe length c of the distal section 425. In one example, the length c is5 mm, the length d is 8 mm, and the angles 1 and 2 are 150 degrees for acatheter configured to be used in a vessel having a 2.5-4 mm diameter.The curved portion 433 can be a configured to adopt the s-shape duringuse of the catheter, as described above with respect to curved portion333.

An exemplary user-activated curved portion 533 (e.g., for use as curvedportion 433) is shown in FIGS. 5A-5D. The curved portion 533 can includea frame (e.g., made of Nitinol or stainless steel) including a series ofcircumferential slits 550 (e.g., laser cuts) that are patterned alongthe circumference of the elongate body 501 within the curved sections525, 526. The frame of the curved sections 525, 526 can also include alongitudinal spine 560 a,b, extending therethrough. The longitudinalspines 560 a,b can be positioned approximately 180 degrees away from oneanother (i.e., on opposites sides of the elongate body 501) and extendsubstantially parallel to the longitudinal central axis of the elongatebody 501. The frame can further include a circumferential spine 561separating the two curved sections 525, 526. Each spine 560 a,b and 561is formed of a substantially solid piece of material that does notinclude slits therein. In use, as the circumferential slits 550 compressand/or overlap with one another during bending, the longitudinal spines560 a,b form the backbone of the curved sections 525, 526. Further, insome embodiments, the frame can be laminated with a layer thereoverand/or under, such as a thin polymer layer, such as Tecothane. In otherembodiments, the frame is not laminated to provide for greaterflexibility.

Referring to FIG. 5D, the slits 550 can be arranged in a pattern that isconfigured to provide flexibility while maintaining structural integrityof the elongate body. Thus, the majority of the slits 550 can have thesame length, but be offset from one another. For example, the slits indistal section 525 can be arranged in rows (1,2) and columns (A, B).Each slit 550 (except the shorter slits bordering the spine 560 a) canhave a length equivalent to the width of columns A+B+A. Further, theslits can be offset from one another by a distance of A+B. Thus, eachcolumn A can include slits from every row 1,2 while column B can includealternating slits (from either row 1 or 2). Column B thus providesstructural integrity to the slitted portion of the device. The slits insection 526 can be similarly arranged, but can be offset such that eachcolumn C (with slits from every row 3,4) is aligned with the centralaxis of each column D (with slits from row 3 or 4). The offset helpsprovide stability to the catheter as it bends.

In some examples, pushing or pulling on a shaft of the catheter, such asthe cutter drive shaft, a pullshaft, or a pullwire can activate thecurved portion 533. That is, as the shaft is pulled back proximally, itcan place compression on the outer elongate body 501, causing the slits550 to compress and/or move over one another while the spines 560 a,bmaintain their length. The resulting s-shape (see FIG. 4B) allows thecutter (just distal to spine 460 a) to be pushed up against the vesselwall.

The slits 550 shown in FIGS. 5A-5D are of a repeated, symmetricalpattern. However, the pattern need not be symmetrical. In someembodiments, the slits can all have the same length. In otherembodiments, some of the slits are longer than others. In oneembodiments, the slits are 0.0016″ wide and 0.0575″ long with a 0.0035″offset from the next row of slits.

Areas of the catheter body having a greater degree of slits will be moreflexible than those having lesser degrees of slits. In one embodiment,the slits can extend all the way through the elongate catheter. In otherinstances, some of the slits may be deeper or shallower than otherswhich also affects the flexibility of the corresponding region. In somevariations of the curved portion, a range of deflection between theflexible segments may be achieved. This may be accomplished throughdifferent geometric patterns of slits, different spacing of the slits,frequency of the slits, size of the slits, and so forth. In someinstances, the degree of stiffness may be adjusted by adding additionalspines of various lengths in certain areas or adjusting the width of thespines.

Referring to FIGS. 6A-6E, another exemplary curved portion 633 (e.g.,for use as curved portion 433) is shown. The curved portion 633 includesa frame having three annular ring spines 661 a,b,c connected together bytwo longitudinal spines 660 a,b. The longitudinal spines 661 a,b,c canbe approximately 180° away from one another. In some embodiments, thedistal ring 661 a,b,c can be beveled at the distal end, as shown in FIG.6C, to allow for dropping or pivoting of the nosecone 605. Further, thespace between the annular ring spines 661 a,b,c and the longitudinalspines 660 a,b can be open or cut-away (i.e., not include the framematerial). In some embodiments, the frame can be laminated to theelongate body 601 with one or more thin polymer layers, such asTecothane. The ring 661 a,b,c can include holes therein for soldering orlaminating the mechanism 633 to the elongate body of the catheter. Inother embodiments, the frame can remain unlaminated to provide forgreater flexibility. When compression is placed upon the mechanism 633,the mechanism 633 can bend away from each of the spines 633, forming ans-shape.

Referring to FIGS. 7A and 7B, in some embodiments, an atherectomycatheter 700 can include a curved portion 777 that includes a fixed jogsection 707 and a flexible section 717. The fixed jog section 707 caneither be proximal to the flexible section 717 (as shown) or distal tothe flexible section 717. In some embodiments, the fixed jog section 707is longer than the flexible section 717. For example, the fixed jogsection 707 can be 5-10 mm, such as 8 mm, and the flexible section 717can be 2-6 mm, such as 5 mm. Further, in some embodiments (as shown),the fixed jog section 707 can include only a single curve rather than adouble curve (e.g., forming a c-shape rather than an s-shape). The angleof the curve can be, for example, 120° to 175°, such as 130° to 160°,such as approximately 145°. The flexible section 717 can be configuredto bend passively during use (i.e., when acted upon by the vessel wall),for example to form an angle of between 90° and 180°, such as 110-170°,such as 130°-160°.

In some embodiments, the curved portion 777 can be made of a laminatedframe. Referring to FIG. 7B, the curved portion 777 can include a framethat includes a plurality of circumferential slits 750 a,b extendingtherethrough. The slits 750 a of the flexible section 717 can extendentirely around the circumference (i.e., include no longitudinal spinetherein) while the slits 750 b of the fixed jog section 707 can end at alongitudinal spine 760 extending through the fixed jog section 707. Anannular spine 761 can separate the flexible section 717 and the fixedjog section 707. The frame can be made, for example, of Nitinol orstainless steel. Further, the frame can be laminated with a thin layerof polymer, such as Tecothane, on one or both sides. In someembodiments, only the fixed jog section 707 is laminated while theflexible section 717 remains unlaminated.

Referring to FIG. 7B, the slits 750 a,b can be arranged in a patternthat is configured to provide flexibility in the flexible section 717while maintaining structural integrity of the elongate body in both theflexible section 717 and the fixed jog section 707. Thus, the majorityof the slits 750 a,b can have the same length, but be offset from oneanother. For example, the slits 750 a in the flexible section 717 can bearranged in rows (1,2) and columns (A, B). Each slit 750 a can have alength equivalent to the width of columns A+B+A. Further, the slits canbe offset from one another by a distance of A+B. Thus, each column A caninclude slits from every row 1,2 while column B can include alternatingslits (from either row 1 or 2). Column B thus provides structuralintegrity to the slitted portion of the device. The slits 750 a of theflexible section 717 can provide flexibility to allow the catheter 700to achieve the desired curvature in any direction when inside the body(i.e., the slits can pull apart on the outside of the curve and compressand/or overlap when on the inside of the curve). For example, theflexible section 717 can bend to align the cutter with the edge of thevessel.

Further, the slits 750 b in fixed jog section 707 (except the shorterslits bordering the spine 560 a) can likewise have a length equivalentto the width of columns A+B+A. Further, the slits can be offset from oneanother by a distance of A+B. Thus, each column A can include slits fromevery row 1,2 while column B can include alternating slits (from eitherrow 1 or 2). In fixed jog section 707, however, the spine 760 can beheat-set to set the angle of the jog, fixing the jog.

Referring to FIG. 8A, in some embodiments, the nosecone 805 can beflexible. That is, the elongate body can include one or more curves (asdescribed herein), and the nosecone 805 can provide additionalflexibility to allow the catheter to take the desired shape. Thenosecone 805 can, for example, include a repeating laser cut patterncovered in a laminate layer. As shown in FIG. 8A, the pattern caninclude a series of spiral slits 850 extending around the circumferenceof the nosecone. some embodiments, the laser cut pattern can be cut outof stainless steal, which can be laminated with a polymer, such asTecothane. Additional flexible nosecone designs are described in U.S.patent application Ser. No. 14/776,749, filed Sep. 15, 2015 titled“TISSUE COLLECTION DEVICE FOR CATHETER,” now U.S. Patent ApplicationPublication No. 2016-0008025-A1 and International Patent Application No.PCT/US2017/035510, filed Jun. 1, 2017 and titled “CATHETER DEVICE WITHDETACHABLE DISTAL END,” both of which are incorporated by referenceherein in their entireties. The flexible nosecone can be used inaddition to, or in place of, any feature of the elongate body curvedportions described herein.

In some embodiments, the curved portions of the elongate catheter bodiesdescribed herein can form a substantially s-shape with two differentinflection points of opposite curvatures. In other embodiments, thecurved portion can include a single inflection point that forms asubstantially C-shape. Further, in some embodiments, one or more of thecurves can be fixed. In other embodiments, one or more of the curves canbe user activated (e.g., by pulling on the driveshaft or a separatepullshaft or wire). Further, any of the designs described herein caninclude a flexible section (e.g., of the elongate body or the nosecone)that allows the catheter to take the desired curvature during use.

In some embodiments, the amount of curvature of the user-adjusted curvedportions can be further adjusted either prior to or during anatherectomy procedure based on the curvatures of the artery and thelocation of the plaque formation. For example, by tensioning a shaft ofthe catheter, the curved portion can constrict and adopt a sharperangle. Alternatively, when the shaft is relaxed, the curved portion canrelax and adopt a wider angle. In such examples, the angles ofdeflection may be adjusted, for example, by 5 to 20 degrees.

In some embodiments, the user-adjusted curved portions can have apre-shaped bend or curvature that can be further adjusted prior to orduring an atherectomy procedure. In other embodiments, the curvedportions can be straight before the user-activated bend is activated.

In any of the embodiments described herein, the nosecone can beconfigured to hold tissue that is debulked by the cutter. Further, thedriveshaft and cutter can be configured to move distally to pack tissueinto the nosecone.

In some embodiments, lamination of a framework can cause the laminatingmaterial to heat and shrink, pushing into open slits and fixing theshape of the frame (e.g., in a pre-shaped jog). For example, the curvedportions 533 and/or 633 can be laminated so as to create a fixed jogthat can either be further adjusted by pulling on the driveshaft or thatremains fixed throughout the procedure. In other embodiments, laminationof the framework can keep the slits open and free of material, allowingfor greater flexibility.

Any of the curved portions described herein may be used alone or incombination with a mechanism to deflect the nosecone. In someembodiments, the nosecone can be deflected by pulling on a cutterdriveshaft. Such deflection mechanisms are described in U.S. patentapplication Ser. No. 15/072,272, filed Mar. 16, 2016, titled“ATHERECTOMY CATHETERS DEVICES HAVING MULTI-CHANNEL BUSHINGS,” now U.S.Pat. No. 9,592,075, and U.S. patent application Ser. No. 15/076,568filed Mar. 21, 2016, titled “ATHERECTOMY CATHETERS AND OCCLUSIONCROSSING DEVICES,” now U.S. Pat. No. 9,498,247, both of which areincorporated by reference in their entireties. In some embodiments,placing further tension on the drive shaft (i.e., after exposing thenosecone) can result in compression being applied to the curved portion,causing the curved portion to assume its final curved configuration.Having both the nosecone deflect and the curved portion can result inbetter tissue invagination and thus better or more efficient tissuecutting.

In embodiments where the nosecone is not deflected, the respectivecutting windows can be optimized so as to allow for automaticinvagination of tissue into the cutting window. Further, having thenosecone not deflect and relying entirely on the curved portion fortissue apposition can advantageously prevent the cutter from escapingfrom the nosecone during packing. Further, having the curved portionalone (i.e., without the nosecone activation) can advantageouslyeliminate having to use additional mechanisms to force a jogmid-surgery, such as pulling or pushing on a shaft, thereby enhancingboth ease of use and enhancing image stability.

The atherectomy catheters having a curved portion described hereinadvantageously allows easier and closer positioning of the atherectomycutter to plaque close to the inner artery walls. That is, the curvedportions can be configured such that the exposed portion of the cutter(e.g., the area extending through the cutter window) moves closer to thevessel wall than the unexposed side of the cutter. This positioning canmake cutting during the atherectomy procedure more efficient.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements (including steps), these features/elementsshould not be limited by these terms, unless the context indicatesotherwise. These terms may be used to distinguish one feature/elementfrom another feature/element. Thus, a first feature/element discussedbelow could be termed a second feature/element, and similarly, a secondfeature/element discussed below could be termed a first feature/elementwithout departing from the teachings of the present invention.

Throughout this specification and the claims which follow, unless thecontext requires otherwise, the word “comprise”, and variations such as“comprises” and “comprising” means various components can be co-jointlyemployed in the methods and articles (e.g., compositions and apparatusesincluding device and methods). For example, the term “comprising” willbe understood to imply the inclusion of any stated elements or steps butnot the exclusion of any other elements or steps.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical rangerecited herein is intended to include all sub-ranges subsumed therein.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

What is claimed is:
 1. An atherectomy catheter for use in a vesselcomprising: an annular cutter; and an elongate catheter body including:a curved portion including a frame having a plurality of annular spinesconnected together by a longitudinal proximal spine and a longitudinaldistal spine, the longitudinal proximal spine positioned approximately180 degrees away from the longitudinal distal spine, wherein thelongitudinal proximal spine and the longitudinal distal spine bend inopposite directions to give the curved portion an s-shape; and anosecone attached to the elongate catheter body, the nosecone configuredto pivot away from the elongate catheter body to expose the cutter,wherein an engagement surface between a distal-most annular spine of theplurality of spines and the nosecone is beveled to provide space for thenosecone to pivot.
 2. The atherectomy catheter of claim 1, wherein theplurality of annular spines includes a first annular spine, a secondannular spine, and a third annular spine, the longitudinal proximalspine connecting the first annular spine and the second annular spine,and the longitudinal distal spine connecting the second annular spineand the third annular spine.
 3. The atherectomy catheter of claim 1,further comprising a cutting window through which the annular cutterextends, the cutting window positioned distal of curved portion and onan outer circumference of the curved portion so as to urge the cutterinto the vessel.
 4. The atherectomy catheter of claim 1, wherein thecurved portion is configured to be activated by pulling or pushing on ashaft of the atherectomy catheter.
 5. The atherectomy catheter of claim1, further comprising at least one laminating layer positioned over orunder the frame.
 6. The atherectomy catheter of claim 5, wherein the atleast one laminating layer is made of a polymer.
 7. The atherectomycatheter of claim 1, wherein the frame is made of metal.
 8. Theatherectomy catheter of claim 1, wherein the distal longitudinal spineis positioned adjacent to an exposed portion of the cutter.
 9. Theatherectomy catheter of claim 8, wherein the distal longitudinal spineis on a same side of the elongate catheter body as the exposed portionof the cutter.
 10. The atherectomy catheter of claim 1, wherein thelongitudinal proximal spine forms a first angle, and wherein thelongitudinal distal spine forms a second angle, the first and secondangles extending in opposite directions, and wherein the first angle isbetween 140 and 160 degrees and the second angle is between 140 and 160degrees.
 11. The atherectomy catheter of claim 1, wherein thedistal-most annular spine of the plurality of spines includes a beveleddistal edge.
 12. A method of performing atherectomy comprising:inserting an atherectomy catheter into a vessel, the atherectomycatheter including: an elongated catheter body, the elongated catheterbody comprising a curved portion, the curved portion including a framehaving a plurality of annular spines connected together by alongitudinal proximal spine and a longitudinal distal spine, thelongitudinal proximal spine positioned approximately 180 degrees awayfrom the longitudinal distal spine, wherein the longitudinal proximalspine and the longitudinal distal spine bend in opposite directions togive the curved portion an s-shape; an annular cutter; and a noseconepivotably coupled to the elongated catheter body; pulling proximally ona driveshaft to pivot the nosecone with respect to the elongatedcatheter body and expose the cutter, wherein an engagement surfacebetween a distal-most annular spine of the plurality of spines and thenosecone is beveled to provide space for the nosecone to pivot; pushingthe curved portion of the elongate catheter body against a first portionof a wall of the vessel to urge the annular cutter against a secondportion of the wall of the vessel; and rotating the annular cutteragainst the second portion of the wall of the vessel.
 13. The method ofclaim 12, wherein the plurality of annular spines includes a firstannular spine, a second annular spine, and a third annular spine, thelongitudinal proximal spine connecting the first annular spine and thesecond annular spine, and the longitudinal distal spine connecting thesecond annular spine and the third annular spine.
 14. The method ofclaim 12, wherein the catheter further comprises a cutting windowthrough which the annular cutter extends, the cutting window positioneddistal of the curved portion and on an outer circumference of the curvedportion, the method further comprising extending the annular cutter outof the cutting window.
 15. The method of claim 12, wherein activatingthe curved portion comprises pulling or pushing on a shaft of theatherectomy catheter.
 16. The method of claim 12, wherein the distallongitudinal spine is positioned adjacent to an exposed portion of thecutter.
 17. The method of claim 16, wherein the distal longitudinalspine is on a same side of the elongate catheter body as the exposedportion of the cutter.
 18. The method of claim 12, wherein activatingthe curved portion causes the longitudinal proximal spine to form afirst angle and the longitudinal distal spine to form a second angle,the first and second angles extending in opposite directions, andwherein the first angle is between 140 and 160 degrees and the secondangle is between 140 and 160 degrees.
 19. The method of claim 12,wherein the distal-most annular spine of the plurality of spinesincludes a beveled distal edge.
 20. An atherectomy catheter for use in avessel comprising: an elongate catheter body; an annular cutter; and acurved portion in the elongate catheter body, the curved portionincluding a frame having a plurality of annular spines connectedtogether by a longitudinal proximal spine and a longitudinal distalspine, the longitudinal proximal spine positioned approximately 180degrees away from the longitudinal distal spine, wherein thelongitudinal proximal spine and the longitudinal distal spine arefixedly bent in opposite directions to give the curved portion a fixeds-shape.
 21. The atherectomy catheter of claim 20, further comprising acutting window through which the annular cutter extends, the cuttingwindow positioned distal of the curved portion and on an outercircumference of the fixed s-shape.
 22. The atherectomy catheter ofclaim 20, wherein the longitudinal distal spine is positioned adjacentto and on a same side of the elongate catheter body as an exposedportion of the annular cutter.
 23. The atherectomy catheter of claim 20,wherein the frame is made of metal.
 24. The atherectomy catheter ofclaim 20, wherein the longitudinal proximal spine forms a first angle,and wherein the longitudinal distal spine forms a second angle, thefirst and second angles extending in opposite directions, and whereinthe first angle is between 140 and 160 degrees and the second angle isbetween 140 and 160 degrees.
 25. The atherectomy catheter of claim 20,further comprising a nosecone configured to pivot away from the elongatecatheter body to expose the cutter, wherein the elongate catheter bodyhas a bevel distal edge configured to provide space for the nosecone topivot.
 26. The atherectomy catheter of claim 25, wherein a distal-mostspine of the plurality of annular spines includes the beveled distaledge.
 27. The atherectomy catheter of claim 20, wherein at least aportion of the frame is heat-set in the fixed s-shape.
 28. Theatherectomy catheter of claim 20, wherein the curved portion islaminated.